D-1465-2019 Class II Terminated
FDA drug recall D-1465-2019 was initiated by Golden State Medical Supply Inc. on Jun 14, 2019 and is designated Class II. Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. The recall status is terminated (terminated Feb 19, 2020). Affected quantity: 32,835 bottles (2,955,150 tablets).
Recall details
- Product Type
- Drugs
- Report Date
- Jul 17, 2019
- Initiation Date
- Jun 14, 2019
- Termination Date
- Feb 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,835 bottles (2,955,150 tablets)
Product description
Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
Reason for recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Distribution pattern
US Nationwide One (1) US government account. No foreign accounts.
Code information
Lot #: GS017042, Expiration 01/2020; GS017043, Expiration 01/2020; GS017044, Expiration 01/2020; GS017541, Expiration 01/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1465-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026